Comparison of azeliac acid 10% gel with microneedling versus tranexamic acid 5% gel with microneedling, on right and left side of face respectively, for treatment of melasma.

An Open label Non-Randomized Split Face Interventional Study to Compare the Efficacy and Safety of Microneedling with Azelaic Acid 10% gel versus Microneedling with Tranexamic Acid 5% gel in the treatment of Melasma. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059632

Enrollment

Registered

2023-11-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L811- Chloasma

Interventions

Intervention1: Microneedling with Azelaic Acid 10% gel: Microneedling with Azelaic Acid 10% gel on right side of face monthly and daily night application of azelaic acid 10% gel on the same side for a

Eligibility

Inclusion criteria

Inclusion criteria: All patients between age 18 to 60 years with bilaterally symmetrical melasma. Patients having Fitzpatrick skin phototype III-V. Not taking any other topical or oral treatment for melasma except for topical sunscreen since last one month.

Exclusion criteria

Exclusion criteria: Patients on oral contraceptive pills or hormone replacement therapy. Patients on anticonvulsive, antidepressant, thyroid medications or anti coagulants. Pregnant women and lactating mothers. Patients with any known systemic illness or endocrinological disease. Patients having history of bleeding disorder. Patients who are ELISA positive for HIV, HbsAg positive. Patient having drug allergy to Tranexamic acid or Azelaic acid. Patients having a keloidal tendency. Patient having any active infection on face.

Design outcomes

Primary

Measure	Time frame
To Compare the Efficacy of Microneedling with Azelaic Acid 10 % gel versus Microneedling with Tranexamic Acid 5% gel in the treatment of Melasma, by calculating Hemi-mMASI Score for each side seperately.Timepoint: 0,1,2,3 Months	—

Secondary

Measure	Time frame
To Compare the Safety of Microneedling with Azelaic Acid 10 % gel versus Microneedling with Tranexamic Acid 5% gel in the treatment of Melasma based on topical side effects, if any, being told by the patient on history or on examination by the doctor.Timepoint: 0 month (Day 1)- At the start of treatment for immediate side effects. End of 1,2,3 Months after starting treatment.;To assess & compare Melasma Quality of Life (MelasQoL) score at the beginning & at end of the study.Timepoint: 0 month (Day 1) & at end of 3 Months.	—

Measure

Time frame

To Compare the Safety of Microneedling with Azelaic Acid 10 % gel versus Microneedling with Tranexamic Acid 5% gel in the treatment of Melasma based on topical side effects, if any, being told by the patient on history or on examination by the doctor.Timepoint: 0 month (Day 1)- At the start of treatment for immediate side effects. End of 1,2,3 Months after starting treatment.;To assess & compare Melasma Quality of Life (MelasQoL) score at the beginning & at end of the study.Timepoint: 0 month (Day 1) & at end of 3 Months.

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Countries

India

Contacts

Public ContactNishant Goel

KAHERs Jawaharlal Nehru Medical College

bhavs1982@gmail.com9422306523

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026